Responsibilities – Researchers are responsible for:
• Protecting the rights and welfare of prospective subjects Protecting Human Research Participants NIH Office of Extramural Research
• Ensuring that pertinent laws, regulations, and institution procedures and guidelines are observed by participating investigators
• Obtaining informed consent and ensuring that no human subject is involved in the research prior to obtaining their consent
• Ensuring that all research involving human subjects receives IRB review and approval before commencement of the research
• Complying with all IRB decisions, conditions, and requirements
• Ensuring that protocols receive timely continuing IRB review and approval
• Reporting unexpected or serious adverse events to the IRB
• Obtaining IRB review and approval before changes are made to approved protocols or consent forms
• Seeking IRB assistance when in doubt about whether proposed research requires IRB
• Assure that research is performed in compliance with Federal Good Clinical Practice Consolidated Guidelines
All materials must be submitted at least two and one half (2 1/2) weeks before the IRB meeting. Submission dates are listed under Scheduled Meetings and Submission Dates.
Required materials:
• Complete copies of the protocol
• Informed consent and protocol submission form
Informed consent:
• General requirements
• University of Minnesota Informed Consent Instruction Module
WCGME-IRB Investigator’s Guide (Revision 2006) :
• IRB Investigator’s Guide (Note: This document is in pdf format and requires Adobe Acrobat Reader.)
WCGME Clinical Trial Protocol Development Template (Revision 2008) and Informed Consent Development Sheet :
• Investigator’s Protocol Development Template
• Informed Consent Template